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Washington, D.C.

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.” Described in an accompanying proposed rule, the Agency proposes that the proper name of all biologics includes a core name and a designated suffix. For originator products, the core name would be the name adopted by the United States Adopted Name (USAN) Council for the drug substance when available. Related, biosimilar or interchangeable products would include the core name of the relevant, previously licensed product and a designated, 4-letter suffix attached by a hyphen.

Essentially, FDA is proposing a unique nonproprietary naming policy for all biologics approved under PHSA 351(a) or 351(k). While ending some speculation on FDA’s policy toward naming of biosimilars, the guidance seeks extensive input from stakeholders regarding the application of a four-letter suffix to distinguish all biologics and biosimilars from one another and whether interchangeable biologics should similarly have unique suffixes or share the same four-letter suffix. FDA summarized its intention with this policy:

"By differentiating biological products from one another that have not been determined by the FDA to be interchangeable, this naming convention is intended to help minimize inadvertent substitution. Inadvertent substitution may lead to unintended alternating or switching of biological products that have not been determined by FDA to be interchangeable. A naming convention that differentiates among biological products also could help facilitate pharmacovigilance for all biological products. By applying this naming convention to all biological products, this approach is intended to: (1) Encourage routine use of designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathways."

In the accompanying proposed rule, FDA provides additional details on its proposed naming policy and the application of this policy to six products. Each of the six products is either a reference product for an approved or publicly disclosed biosimilar product application or a biological product that is either biosimilar to or related to one of these reference products.

Comments on the guidance, which has been assigned Docket No. FDA-2013-D-1543, are open through October 27, 2015. (Although, per FDA regulation, comments on a guidance may be received at any time.) Comments on the proposed rule, including the assignment of proper names, should be sent to Docket No. FDA-2015-N-0648, which is open through November 12, 2015.